Adhesive-based varicose vein treatment

ABSTRACT

An intraluminal member can be used to deliver an adhesive to a vein while causing the vein to spasm, thereby controlling adhesive migration and improving procedure efficacy.

SUMMARY

Conventional adhesive-based varicose vein treatment systems requireapplication of external pressure on the skin overlying the site ofinjection to compress the vein, reduce the vein diameter and therebycontrol migration of the adhesive as well as provide approximation ofthe opposing vein walls to enable effective gluing and occlusion of thevein lumen. Because external pressure can be difficult to applyconsistently, and because the consequences of adhesive migration intothe deep venous system are potentially so grave, adhesive-based varicosevein treatment may be improved with techniques that achieve reliable andconsistent circumferential vein diameter reduction. The presentinvention is a device that perturbs the inner wall of the vein to inducecircumferential vasospasm at or near the site of adhesive injection.Causing spasm at the time of adhesive delivery would provide such finer,more reliable vein diameter reduction and thereby improve control ofadhesive migration as well as improve efficacy of the procedure.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows an embodiment of an assembly of a vascular treatmentdevice.

FIG. 2 illustrates a longitudinal cross-sectional view of the embodimentillustrated in FIG. 1.

FIG. 3 shows a longitudinal cross-sectional view of a handle.

FIG. 4 illustrates a longitudinal cross-sectional view of a cartridge.

FIG. 5 shows the cartridge illustrated in FIG. 4 with a syringe and astopcock attached.

FIG. 6 shows a perspective view of an embodiment of a vascular treatmentdevice having a single syringe support.

FIG. 7 illustrates an exemplary assembly of the handle of the embodimentdepicted in FIG. 5.

FIG. 8 depicts a top plan view of a portion of the handle illustrated inFIG. 7.

FIGS. 9-10 depict various embodiments of wire distal ends.

FIGS. 11-13 illustrate transverse cross-sectional views of variousembodiments of wire distal tips about which springs are wrapped.

FIGS. 14-14A, 15-15A, 16-16A, 17-17A, 18-18A, 19-19A, 20-20A, 21-21A,22-22A, 23, and 24 depict various embodiments of wire distal ends.

DETAILED DESCRIPTION

The ablation of superficial veins that have lost their ability to pumpblood to the heart has known beneficial therapeutic effects. The use ofadhesives to stop flow in veins, by forming a permanent hardenedoccluding mass is limited because of concerns of allowing adhesive toenter the deep system. The migration of adhesive into undesirable,otherwise healthy sections can have devastating effects. For example,the use of adhesive to occlude a great saphenous vein, a common veinclosure procedure, could result in migration of the adhesive into thedeep system, for example, into the common femoral vein. If glue migratesinto the deep system it will harden and occlude the deep vein; clot willform proximal and distal to the glue mass and an immovablenon-correctable deep vein thrombosis (DVT) will result. The affectedextremity will be painful, swollen, and the veins will be engorged. Clotcould dislodge and travel to the lungs, causing a pulmonary embolism(PE) associated with a substantial mortality rate). The medicalemergency of acute deep vein thrombosis is usually treated by breakingdown the clot using thrombolytic agents and anticoagulation (bloodthinners). In this case, however, the hardened glue mass is notremovable. There is no apparent way to correct the condition. Effortsmight be made to surgically bypass the hardened mass but such proceduresare known to be risky and have limited success rate. Current proceduresto limit the adhesive to the treatment zone and prevent it frominadvertent migration involve adjusting the viscosity of the adhesivesto prevent movement, as well as applying external compression by thehand or ultrasound transducer to block passage of the adhesive intoundesirable locations. The viscosity approach is quite limiting andcomplicates both the adhesive delivery system and placement of theagent. External vein compression is unreliable.

The present inventors have discovered that the use of an intraluminalmember, such as a rotating (dispersion tip) wire catheter, is aneffective, safe approach to deliver an adhesive to veins and arterieswhile controlling adhesive migration. The rotating dispersion tip incombination with a sclerosant and adhesive or adhesive alone causesvasospasm. The vein consistently and reliably demonstratescircumferential narrowing and a marked reduction in diameter, causingcomplete occlusion of the treated vein at the treatment site. Withspasm, the vein is occluded distal to and at the adhesive injectionpoint, thereby preventing adhesive migration and collateral damage. Thespasm blocks adhesive flow to the deep system and also reduces therequired volume of adhesive. It provides more effective and reliablevein occlusion. There is no need to block flow to the deep system usingexternal compression or any other methods such as a mechanical plug orballoon. Obstructing flow through spasm caused by the device makes for asafer system.

The use of glue with sclerosant makes the sclerosant procedure safer. Anoperator can inject sclerosant and adhesive simultaneously, or serially.Either the sclerosant or the adhesive or both can be injected while therotating wire is perturbing the vein to promote vasospasm. Also, anoperator could serially activate the rotating wire device to cause spasmin the target vein, remove the wire, and then inject the sclerosantand/or adhesive into the treatment zone.

Combining the use of adhesive with a rotating wire has the benefit thatthe spinning tip of the wire will evenly distribute the adhesiveradially making the adhesive more effective.

The tip can be configured to cause back flow proximal to the injectionpoint, or the tip configuration may be arranged to provide back flowdistal to the injection point to further limit the migration of adhesiveinto unwanted vein segments. The tip of the device may be positioned atthe end of the treatment zone and pulled back or down through thetreatment zone. For example, in the great saphenous vein, the tip couldbe positioned near the sapheno-femoral junction and is pulled away fromthe junction and through the treatment zone. Because it is highlyundesirable (dangerous) to allow adhesive to enter the deep system (inthis example, into the femoral vein), back flow is stimulated in adirection away from the deep system.

Another alternative is to use rotation in a short segment of vein andinject without rotation through the remainder of the treatment zone.

A variety of known adhesives can be used. Usable adhesives can cure indifferent ways, for example, chemically, or by UV activation. A rotatingwire catheter can be configured to deliver UV light at the tip toactivate the adhesive. In this manner, adhesive can be delivered throughthe catheter in a low-viscosity state, which helps minimize the requireddiameter of the catheter lumen, and then activated when applied or aboutto be applied. Alternatively, chemically-activated adhesive can be used,with the activator added when the adhesive is applied or about to beapplied.

A wide variety of adhesives are suitable for use, principal among themacrylic-based glues, primarily cyanoacrylates, such as2-octyl-cyanoacrylate (DERMABOND,™ Ethicon) and N-butyl-2-cyanoacrylate(HISTOACRYL,™ B. Braun, Germany; GLUBRAN,™ GEM Srl, Italy; TRUFILLN-BCA,™ Cordis Neurovascular, Inc., US). Other adhesives includeBIOGLUE™ surgical adhesive (Cryolife), which is composed of purifiedbovine serum albumin (BSA) and glutaraldehyde; KRYPTONITE™ adhesive(Doctors Research Group, Inc. of Connecticut.); and fibrin glue. Certainnonadhesive materials, such as the ONYX liquid embolic system (ev3) mayalso be suitable.

Once adhesive is delivered to the targeted portion of the vein, theadhesive hardens or cures, leaving the vein permanently occluded.

A method of permanently occluding a vein through the combined spasm ofthe vein and injection of an adhesive can be carried out as follows.

An operator can advance an elongated intraluminal member from an accesssite and into the vein. The intraluminal member will include aperturbing portion configured to perturb an inner vessel wall of thevein under user control when performing a defined movement. For example,the perturbing portion can be a tip of a rotatable wire and the definedmovement can include rotation of the tip, an embodiment explained inmore detail below. The defined movement can also include moving the tiplongitudinally (i.e., proximally or distally in the vein); thelongitudinal movement can be performed simultaneously or serially withrotating. The defined movement can have other effects as well; forexample, a wire tip can have a blade configuration similar to apropeller that generates a backflow of blood in the vein when the tip isrotated.

The operator perturbs the vessel wall by performing the defined movementof the perturbing portion of the intraluminal member, thereby inducing aregion of the vein to spasm and reduce its diameter.

The operator also injects sufficient adhesive at or near thereduced-diameter region of the vein to occlude the vein permanently. Theocclusion may be formed proximal to, distal to, and/or coincident withthe reduced-diameter region of the vein. The adhesive may be injectedwhile the defined motion is being performed, or after the defined motionis performed. Sclerosant may also be injected. The sclerosant may beinjected simultaneously with the adhesive or serially with the adhesive,at any time in relation to the performance of the defined motion.

The treatment site may be observed during treatment, such as byultrasound administered by an ultrasound probe placed on the skinoverlying the treatment site. Administration of adhesive can be delayeduntil vein spasm is observed, to help ensure that the adhesive is notintroduced into the vasculature until the vein has been prepared tolimit adhesive migration.

One example of a rotating wire catheter is described below.

A vascular treatment device may be used for ablating blood vessels, suchas varicose veins, and for treating thrombosis by macerating a clot andinjecting a thrombolytic drug, among other uses. A vascular treatmentdevice may include a rotatable wire, so sized and shaped for ablatingblood vessels, coupled to a cartridge that is engageable to a handle.The wire may thus be indirectly engaged with a motor in the handle suchthat the wire rotates when the motor is turned on. When the device isused for treating a varicose vein, the rotating wire may perturb thevessel to cause vasospasm, a condition in which blood vessels spasm, andmay cause damage to the vessel wall to promote sclerosis.

FIG. 1 shows an embodiment of an assembly of a vascular treatment device10 having a handle 12 and a cartridge 14. The cartridge 14 may be sosized and shaped to engage to the handle 12 by fitting one component toanother as shown. An embodiment of the handle 12 is shown in greaterdetail in FIG. 3. The handle may define a receptacle 29 in which themale coupling 30 is positioned to receive the female coupling 40 of thecartridge 14 when the cartridge 14 and the handle 12 engage. The handle12 may include a motor 22, a trigger 26, and a male coupling 30. Themale coupling 30 may be connected to the motor 22 in such a way that themotor rotably drives the male coupling upon activation. A potentiometer24 may be electrically coupled to the motor 22 to control a speed of themotor. The trigger 26 may be mounted on the handle and transitionablebetween a first state, which does not couple the motor to a power sourceelectrically, and a second state, which couples the motor to a powersource.

The handle 12 may also include a power source 20 and a microswitch 28connected to the motor 22 by a wire 32. The microswitch 28 may beinterposed in an electrical circuit connecting the trigger 26 and themotor 22. The microswitch may be biased to an open position such thatthe circuit between the trigger and the motor is open. When thecartridge 14 is engaged in the handle 12, the cartridge may pressagainst the microswitch, causing it to transition to a closed state,thereby completing the electrical circuit connecting the trigger 26 andmotor 22. For example, the microswitch may include two contacts with aconductor that is attached to one contact and disconnected from thesecond contact when the microswitch is in an open state. In oneembodiment, the conductor may include a strip of metal that hangs in thechannel into which the cartridge is slid during engagement with thehandle. As the cartridge is engaged in the handle, it pushes the metalstrip out of the channel and into connection with the second contact ofthe microswitch. One advantage gained from such configuration may bethat a user will not be able to activate the device inadvertently bypressing on the trigger before he/she is ready to use the device, i.e.,before the cartridge 14 is fully engaged to the handle 12.

The handle may 12 also include a switch 16 as shown in FIG. 3. Theswitch 16 allows the cartridge 14 to be received by, and secured in, thehandle 12. The switch may include a grip 15 to permit a user to operatethe switch with a finger. The switch may also include a gate 17 thatalternately obstructs or locks the cartridge, depending on the gate'sposition. For example, a user may put a thumb on the grip 15 and pushthe switch 16 away from the handle grip 25 to transition the switch 16from a first position, in which gate 17 is positioned in the channel andso prevents engagement of the cartridge 12 and the handle 14, to asecond position in which gate 17 is moved out of the channel and therebypermits engagement of the cartridge and the handle. Upon release of thebiased switch 16, the gate 17 may fit into a complementary detent in thecartridge and thereby help keep the cartridge engaged with the handle.

The gate 17 may be biased to the first position by a spring 23contacting the handle. As the user pushes the switch 16 away from thehandle grip 25, the switch 16 will push on the spring, thereby creatinga restoring force to urge the switch to its original position once theuser releases the switch.

As noted above, the gate 17 may be further transitionable to a thirdposition which prevents disengagement of the cartridge 14 from thehandle 12. For example, the gate 17 may be forced into the detent 35(shown in FIG. 4), defined by the cartridge 14, when the biased switch16 returns to its original position from the second position to lock thecartridge to the handle.

One or more portions of the handle 12 may define a trigger ring 18 inwhich the trigger is at least partly disposed and about which the handleis so arranged as to be balanced when supported from only one or moreportions of the handle that define the trigger ring. In this manner, auser may balance the handle simply by supporting it with a singlefinger, such as an index finger, against a portion of the handle thatdefines the trigger ring 18. As motor 22 may well be the heaviestcomponent in the handle, it can be positioned below the trigger 26 asshown in FIG. 3 to reduce the bending moment applied by the motor 22 ona finger supporting the handle by the trigger ring, thereby reducingfatigue experienced by the user.

The handle 12 may be formed by joining two outer casing pieces together.

An embodiment of the cartridge 14 shown in FIG. 1 is illustrated ingreater detail in FIG. 4. The cartridge 14 may include a female coupling40, a wire 33 (shown as a broken line), and a sheath 32 fixed to andextending from the cartridge 14. The wire may be fixed to the femalecoupling 40; for example, the wire's proximal tip may be bentapproximately 90 degrees to fit through a channel that is sized andshaped to receive the bent end of the wire. A setscrew may be receivedin the female coupling 40 and/or an appropriate adhesive may be used tosecure the wire and prevent it from rotating with respect to the femalecoupling.

The sheath 32 may define a lumen through which the wire 33 runs. Thesheath 32 may have a wide range of inner and outer diameters. In someembodiments, the sheath may have an inner diameter in the range of from0.022 inches to 0.048 inches. In some embodiments, the sheath 32 mayhave an outer diameter in the range of from 0.025 inches to 0.051inches. The outer diameter of the sheath may also be in the range thatis consistent with the standard needles having corresponding innerdiameters. For example, the sheath may be so sized and shaped to beinsertable in a standard needle or vascular sheath having an innerdiameter in the range of from 0.0035 inches to 0.1060 inches, or from0.0160 inches to 0.0420 inches, or from 0.0420 inches to 0.0630 inches,or from 0.0115 inches to 0.0630 inches. The maximum outer diameter ofthe sheath may be less than 0.035 inches to allow the sheath to beinserted through an intravenous needle or catheter having an innerdiameter of less than 0.0039 inches to allow a wider range ofpractitioners to perform the procedure. Needles, catheters or vascularsheaths with an outer diameter greater than 0.079 inches (6 French, Fr)or 0.092 inches (7 Fr) typically require insertion to be performed by avascular surgeon or interventional radiologist.

The sheath 32 may also include external markings at regular intervalswhich may guide the user to monitor the insertion or removal speed ofthe device 10.

One exemplary embodiment depicting a reservoir connectible to thecartridge may include a syringe 44, a stopcock 46, and a plunger 48 asshown in FIG. 5. The syringe 44 may be in fluid communication with thebore of the sheath 32 for releasing a substance at the wire distal end,such as a sclerosant (examples of which include polidocanol, sodiumtetradecyl sulfate, and hypertonic saline) and/or adhesive. In thismanner, physical perturbation by the wire may be synergisticallycombined with drug or adhesive treatment to improve device efficacy.

The handle 12 may include a support 19 (shown in FIG. 3) so positionedas to receive the syringe 44. The support 19 may be so sized and shapedto be compatible with the standard syringes and may prevent the syringefrom falling out during injection, especially if the material beinginjected has high volume and/or viscosity and requires significant userthumb pressure upon the syringe. When the cartridge 14 with an attachedsyringe 44 is engaged to the handle, the syringe 44 may snap onto thesupport 19. As shown in FIG. 1, the support may be formed from twobrackets which cradle the syringe. An alternative embodiment shown inFIGS. 6 and 7 includes a support formed from a single hook that wrapspartially around the syringe. These embodiments allow use of the devicewith the right as well as left hand, depending on the user's preferenceand/or the patient's position on the treatment table.

The handle 12 and the syringe 44 may be so sized, shaped, and positionedas to permit a user to actuate the trigger 26 with the index finger of ahand and simultaneously depress a plunger 48 into the syringe with thethumb of the same hand, allowing a treatment drug to be deployed fromthe syringe through the sheath while the wire 33 is rotating. Forexample, a user may hold the handle by positioning the handle grip 25 inthe center of the palm and wrapping third, fourth, and fifth fingeraround the handle grip and putting an index finger through the triggerring 18 and if needed, placing a thumb to depress the plunger to releasetreatment drug into the syringe. The handle may be so designed to allowboth right- and left-handed users to operate.

The stopcock 46 shown in FIG. 5 may allow reloading of fluid (such asadhesives and/or sclerosants) and also changing the fluid concentrationof composition as well as mixing of fluid with gas. For example, air canbe mixed for generating foam as well as agitating an existing mixtureand also recreating the foam, because the foam has a limited duration(typically a minute or less) before the fluid and gas start to separate.The stopcock 46 may allow the fluid composition mixture to be agitatedwithout disconnecting the syringe from the cartridge or without stoppingthe procedure.

A standard Y hemostasis connector 34 as shown in FIG. 4, or other Yhemostasis connector, may be used to aid in fluid communication betweenthe syringe 44 and the lumen defined by the sheath 32. A Y-hemostasisconnector 34 may be connected to the female luer hub 31 and to thetubing nut 36 to prevent the fluid from leaking into the regioncontaining the motor 22. An O-ring may be used to prevent leaks aroundthe wire shaft. Wire tubing 42 may be so sized and shaped to receive thewire 33 and attached to the female coupling 40. Combining the abovementioned components may allow the motor to rotate the wire withoutincreasing the torque beyond the appropriate working range. The motormay spin in the range of from 500 to 3000 rpm-4000 rpm for varicose veindestruction and thrombectomy procedures. The handle may also include abuilt-in RPM display for user to read the speed or may include anelectrical port through which the speed may be measured by an externalmonitor.

The male coupling 30 on the handle 12 may be biased toward an expandedstate and transitionable from the expanded state to a contracted state.The female coupling 40 may be so sized and shaped as to transition themale coupling 30 from the expanded state to the contracted state duringengagement of the handle 12 and the cartridge 14. As the male coupling30 and the female coupling 40 fully engage each other, the male couplingdisplaces the female coupling detents 13 to allow the female coupling toslide within the cartridge.

Attaching the female coupling 40 to the male coupling 30 thereby causesthe sheath 32 to slide back relative to the wire. This occurs becausethe sheath is fixed to the cartridge, while the wire is fixed to thefemale coupling. As the cartridge is fully seated in the handle, thefemale coupling is pushed forward in the cartridge. So when the femalecoupling 40 is not engaged by the male coupling 30, the sheath 32 maycover the distal end of the wire 33, allowing it to be safely advancedin the patient's vasculature; and when the female coupling 40 is engagedby the male coupling 30, the sheath may reveal the distal end of thewire. Consequently, when the female and male couplings are engaged (1)the distal tip of the wire is revealed, and (2) the wire is operablycoupled to the motor 22 through the female and male couplings, to allowthe motor to rotate the wire 33. As noted above, the cartridge may alsotrip a lever arm coupled to the microswitch 28 to complete a circuitbetween the trigger 26 and the motor 22. The male coupling 30 may be sosized and shaped as to return to the expanded state once the cartridge14 and the handle 12 are fully engaged as described earlier.

The female coupling may be disengaged from the male coupling to re-coverthe distal tip of the wire when the wire is to be removed for the siteof use, or if a treatment is interrupted. Disengaging the femalecoupling from the male coupling slides the wire 33 with respect to thesheath 32 (attached to the cartridge fixed to the handle); as a resultthe tip of the wire is no longer exposed, allowing it to be safelyremoved. This mechanism may protect the tip of the wire 33 prior to useand also protect the blood vessels and other body tissues during removalor repositioning of the device.

The male coupling 30 may have at least two prongs separated by slittedportions to facilitate the transition from the expanded state to thecontracted state. The male coupling may be made with polycarbonate,plastic, or other materials which allow transitioning between anexpanded state and a contracted state.

In some embodiments, the vascular treatment device 10 may be of a singlepiece construct having a handle and a cartridge. The cartridge may beassembled to the handle during manufacturing and be able to transitionwithin the handle between a first position, where the male and femalecouplings are not engaged, and a second position, where the male andfemale couplings are engaged. An embodiment of such device may allow thecartridge to slide back and forth within a predetermined range, such asthe first and the second position, in the groove defined by the handle,but the cartridge may not disengage itself from the handle. A sheath maybe fixed and extend from the cartridge and define a lumen through whichthe wire runs. The cartridge may also include a syringe to be receivedby a support mounted on the handle.

In this embodiment, the handle may include a motor, a motor coupling, atrigger, and a power source. The wire having a main shaft, a distal end,and a proximal end which is fixed to the motor coupling may be attachedto the motor coupling. The motor coupling may be rotably driven by themotor. The trigger may be mounted on the handle and be transitionablebetween a first state, which does not couple the motor to a power sourceelectrically, and a second state, which couples the motor to a powersource. The handle may also include a microswitch to permit trigger andthe motor to be electrically coupled to one another.

At the first position, the cartridge may cover the distal tip of thewire. At the second position, the cartridge (1) exposes the distal tipof the wire from the sheath, and (2) completes a circuit between thetrigger and the motor by tripping a lever arm coupled to themicroswitch. Therefore, the single piece construct vascular treatmentdevice may allow a user to obtain similar functionality as the deviceexplained earlier and shown in FIG. 1.

FIG. 6 illustrates another embodiment of vascular treatment device 10.The handle may have a support 19 for the syringe 46 in the form of ahook, as described above. This embodiment may be assembled by mating twocasings as shown in FIG. 7. The syringe may snap onto the support andremain in position during the use of the device. The support 19 (and/orhandle 12) may be made of SLA resin or other materials that would allowthe support to withstand the snapping force applied by the syringe.

FIG. 8 shows a top view of the end of an alternate embodiment of handle12 having a notch 80 for retaining the cartridge 14 (not shown) to thehandle 12. In the previously mentioned embodiments, the handle had aswitch that may be coupled to a gate which held the cartridge to thehandle. In this configuration, the notch 80 may prevent the cartridgefrom disengaging from the handle. In use, a user may slide the cartridgeinto the handle and then “cock” the cartridge into notch 80 to preventthe cartridge from slipping out of the handle.

A wide variety of distal wire tips may be used; FIGS. 9-11, 14-14A,15-15A, 16-16A, 17-17A, 18-18A, 19-19A, 20-20A, 21-21A, 22-22A, 23, and24 show several examples.

FIG. 9 shows an embodiment of a wire 33 having a proximal end 50, adistal end 52 and in proximal-to-distal order, a first segment 54, asecond segment 56 , and a third segment 58. The first segment 54 mayextend between the main shaft 51 and the second segment 56 and may bebiased to a first included angle a that is defined between the mainshaft 51 and the first segment 54 and is less than 180 degrees. Thesecond segment 56 may extend between the first segment 54 and the thirdsegment 58 and may be biased to a second included angle β that isdefined between the first segment 54 and the second segment 56 and isless than 180 degrees. The third segment 58 may extend from the secondsegment 56 to a free end and may be biased to a third included angle γthat is defined between the second segment 56 and the third segment 58and is less than 180 degrees.

The second included angle may be greater than the first included angle.The sum of the first included angel and the third included angle, minusthe second included angle, may be in the range of about 70 degrees toabout 110 degrees. The sum of the first included angle and the thirdincluded angle, minus the second included angle may be in the rangeabout 80 degrees to about 100 degrees. The sum of the first includedangle and the third included angle, minus the second included angle maybe about 90 degrees.

The third segment 58 of the wire 33 may have a length that is smallerthan the inner diameter of the sheath 32. For example, the third segment58 may have a length of less than 0.028 inches or it may have a lengththat is equal to or smaller than two-thirds of the inner diameter of thesheath 32.

The perpendicular distance measured from a center axis of the main shaft51 to the free end may be less than 0.3 inches. The first segment 54 andthe second segment 56 each may have a length in the range of about 0.2inches to about 0.3 inches, or in the range about 0.24 inches to about0.26 inches. The length of the first segment 54 may be in the range ofabout 0.248 inches to about 0.25 inches, and the length of the secondsegment is in the range of about 0.25 inches to about 0.252 inches. Inone embodiment, the length of the first segment 54 may be 0.249 inches,and the length of the second segment is 0.2504 inches.

The distal end 52 of the wire 33 may include at least two linearsegments oriented at a non-zero angle relative to one another. Having atleast two linear segments may allow the distal tip of the wire to tuckinto a sheath without touching the wall of the sheath, and it may alsoallow the main shaft of the wire to run along the vessel wall while thetip (for example, the third segment) of the wire digs into the vesselwall.

The wire tip located on the distal end 52 may have a wide variety ofconfigurations, depending on the intended use. The wire shape may be“atraumatic,” meaning that it may be shaped such that insertion causeslittle or no spasm or damage to the vessel. For example, FIG. 10 shows adistal end 52 terminating with a hemispheric free end. The hemisphericend may be textured or mechanically or chemically altered to create aroughened surface. Other atraumatic tips may include an end having afull radius, or a J-curved shape, or simply a curved shape.

FIG. 10 shows an atraumatic tip having a sleeve extending from thehemispheric shape along the wire 33 towards the proximal end of thewire. The sleeve 70 can add strength to the distal tip, therebyincreasing the scrapping force and increasing the contact surface areato prevent detachment of the hemispheric tip 72.

In other embodiments, the distal tip 52 may be “aggressive” and be bentor curved so that it scrapes the vessel wall. FIG. 9 shows the distalend 52 having a flat free end with a sharp edge around. An aggressivedistal tip 52 may also be created by beveling an edge to create a sharppoint. The distal tip having a cutting blade, like a shark's fin, mayalso be aggressive. The distal tip 52 may be roughened to make thedistal tip cut more aggressively and/or cause spasm to the blood vesselwall.

A roughened surface may be formed by subjecting an initially smoothsteel to abrasion, machining, blasting, chemical etching such as acidetching (for example, nitric acid, hydrofluoric acid, hydrochloric acid,and/or sulfuric acid). A roughened outer surface may also be created byrolling a sheet metal, such as a sheet forming the sleeve 70, onto anirregularly shaped guide to create surface irregularity.

Also, the outer surfaces of the first, the second, and/or the thirdsegments may be coated with an abrasive to roughen the surface. Othersurface treatments may include a bastard cut file type or diamond grit.For example, 30 grit diamond may produce an aggressive surface and 200grit diamond may produce a non-aggressive surface.

During use, especially with a roughened tip, the wire may beperiodically re-encased in the sheath to help dislodge debris from thewire tip and keep the device operating normally.

An aggressive surface may also be formed on the first segment 54 and/orthe second segments 56 of the wire 33 by introducing a screw threadedprofile with a second wire along the length of the wire 33 by followinga screw flights of various shapes such as a square, or a rhomboid, or atrapezoid, or a parallelogram, or an ellipse, or a triangle, or apentagon.

FIG. 10 shows an embodiment having a first segment 56 with a sleeve 70having a roughened outer surface using one of various methods mentionedearlier. In addition to showing a roughened surface treatment, FIG. 10further illustrates a wire with a weight added at the distal tip, inthis case the weight is added by a sleeve with a roughed outer surface.The weight may be centered on the wire or eccentrically positioned. Aneccentric weight may cause the wire to flail about during rotation. Theflailing may perturb the vessels more aggressively compared to a wirewith centrically added weight.

The distal end 52 of the wire 33 may also include a curved segment. Thecurvature of the curved segment may be constant, or it may follow othercurves, such as a sector of an ellipse or an oval. The distal end 52 ofthe wire 33 may also have a straight segment distal to the curvedsegment. Similar to the embodiments with a constant curvature, thecurvature of the curved section with a straight segment may be constantor it may follow previously mentioned shapes.

A spring 90 may be attached from the distal end 52 of the wire 33 alongthe first segment 54 and/or the second segment 56 to create anaggressive cutting surface. The ends of the spring may be brazed atmultiple points. The spring 90 may follow the various profiles mentionedearlier. FIGS. 11-13 illustrate cross-sectional views of a springfollowing screw flights of a square, a trapezoid, and a pentagon,respectively.

The sharp corners of the various profiles (for example, a square, atriangle, a parallelogram, a pentagon) may dig into the blood vesselwall and ablate the vessel wall. The wire 33 may have a hemispheric or aflat free end depending on the intended use. The hemispheric end or flatfree end may also be textured or roughened.

FIGS. 14-14A show a wire similar to that shown in FIG. 9 having first,second, and third linear segments distal to the main shaft.

FIGS. 15-15A show a wire similar to that shown in FIGS. 14-14A, in whichthe free end of the third segment is hemispherical.

FIGS. 16-16A show a wire having a curved segment distal to the mainshaft, and in which the free end of the curved segment is hemispherical.

FIGS. 17-17A show a wire similar to that shown in FIG. 10 having first,second, and third linear segments, with weight added at the distal tip.

FIGS. 18-18A show a wire having a single linear segment distal to themain shaft, in which the linear segment terminates with a ball-shapedfree end.

FIGS. 19-19A show a wire having a single linear segment distal to themain shaft, in which the distal tip has added weight and the free end ishemispherical.

FIGS. 20-20A show a wire having two linear segments distal to the mainshaft, in which the second linear segment terminates with a ball-shapedfree end.

FIGS. 21-21A show a wire having two linear segments distal to the mainshaft, in which the second linear segment has added weight andterminates with hemispherical free end.

FIGS. 22-22A show a wire similar to that shown in FIGS. 14-14A, havingthree linear segments in which the third segment terminates with a sharpfree end.

FIGS. 23-24 show wires having a spring wrapped around the distal portionof the wire.

1. A method of permanently occluding a vein through the combined spasmof the vein and injection of an adhesive, comprising the followingsteps: advancing an elongated intraluminal member from an access siteand into the vein, wherein the intraluminal member comprises aperturbing portion configured to perturb an inner vessel wall of thevein under user control when performing a defined movement; perturbingthe inner vessel wall by performing the defined movement of theperturbing portion of the intraluminal member, thereby inducing a regionof the vein to spasm and reduce its diameter; and injecting sufficientadhesive at or near the reduced-diameter region of the vein to occludethe vein permanently.
 2. The method of claim 1, wherein the adhesive isinjected in such as manner as to occlude the vein at a location distalto the region of spasm.
 3. The method of claim 1, wherein the adhesiveis injected in such as manner as to occlude the vein at a locationproximal to the area of spasm.
 4. The method of claim 1, wherein theperturbing portion is a tip of a wire and the defined movement includesrotating the tip so that the tip contacts the inner vessel wall.
 5. Themethod of claim 4, wherein the defined movement further comprises movingthe tip of the wire longitudinally along the vein.
 6. The method ofclaim 5, wherein the tip of the wire is simultaneously rotated and movedlongitudinally.
 7. The method of claim 4, wherein the wire tip has ablade configuration that generates backflow of blood in the vessel whenthe wire is rotated.
 8. The method of claim 1, further comprisinginjecting sclerosant at or near the reduced- diameter region of thevein.
 9. The method of claim 8, wherein the sclerosant and the adhesiveare injected simultaneously.
 10. The method of claim 8, wherein thesclerosant is injected first, and the adhesive is injected after thesclerosant.
 11. The method of claim 8, wherein the adhesive is injectedfirst, and the sclerosant is injected after the adhesive.
 12. The methodof claim 1, further comprising observing the treatment site and waitingto inject the adhesive until a reduction in the vein diameter isobserved.
 13. The method of claim 12, wherein observing comprisesultrasound imaging.
 14. The method of claim 1, further comprisingexposing the adhesive to UV light so as to cure the adhesive.
 15. Themethod of claim 1, further comprising applying external compression onthe catheter tip before, during, or after injection of sclerosant. 16.The method of claim 15, wherein the external compression is applied withan ultrasound probe.
 17. Method of claim 15, wherein the spasm isaccentuated by external compression on the catheter tip at the injectionsite with the palm of the operator.
 18. The method of claim 15, whereinthe adhesive is injected in such as manner as to occlude the vein at alocation distal to the region of spasm.
 19. The method of claim 15,wherein the adhesive is injected in such as manner as to occlude thevein at a location proximal to the area of spasm.
 20. The method ofclaim 15, wherein the perturbing portion is a tip of a wire and thedefined movement includes rotating the tip so that the tip contacts theinner vessel wall.
 21. The method of claim 20, wherein the definedmovement further comprises moving the tip of the wire longitudinallyalong the vein.
 22. The method of claim 21, wherein the tip of the wireis simultaneously rotated and moved longitudinally.
 23. The method ofclaim 20, wherein the wire tip has a blade configuration that generatesbackflow of blood in the vessel when the wire is rotated.
 24. The methodof claim 15, further comprising injecting sclerosant at or near thereduced-diameter region of the vein.
 25. The method of claim 24, whereinthe sclerosant and the adhesive are injected simultaneously.
 26. Themethod of claim 24, wherein the sclerosant is injected first, and theadhesive is injected after the sclerosant.
 27. The method of claim 24,wherein the adhesive is injected first, and the sclerosant is injectedafter the adhesive.
 28. The method of claim 1, further comprisingobserving the treatment site and waiting to inject the adhesive until areduction in the vein diameter is observed.
 29. The method of claim 28,wherein observing comprises ultrasound imaging.
 30. The method of claim15, further comprising exposing the adhesive to UV light so as to curethe adhesive.